Sr. Product Development Quality Engineer (mfg exp req)

Senior Quality EngineerLocation: Greater Miami Area, FL (near Amelia Earhart Park) Salary: $120,000-$140,000+ (Negotiable, DOE) + Company-Based Annual Bonus Excellent Benefits: Medical (100% paid premiums for employees, 80% for family), Dental, Vision, 401k, Life, Disability, HSA, Vacation, Holidays, Sick Time Job Type: Full-Time; Monday-Friday Sponsorship is not availableSenior Quality Engineer (manufacturing exp. req.) Description Our client is seeking a Sr. Quality Engineer to join their team in the Miami area. They are a small, highly capable group that manufactures their own medical devices while also supporting full product design and development. This is a hands-on role centered around quality events and manufacturing process improvement within a collaborative team. You will lead investigations, develop manufacturing and inspection procedures, and play a key role in ensuring consistent, high-quality production. You will spend about 50% of your time supporting quality initiatives, 40% on manufacturing processes, and 10% supporting product development activities. You will also act as a bridge between the Quality team (4) and Manufacturing team (5), supporting cross-functional collaboration and contributing to continuous improvement efforts If you enjoy variety in your day and working across functions rather than staying in a narrowly defined role, this could be a great fit. This opportunity offers the chance to make a meaningful impact and have greater influence within a smaller, agile team. In this environment, your ideas will be heard and put into action, something that can be harder to find in larger organizations. They also offer strong benefits for a company of this size, including 100% employer-paid premiums for employees and 80% for dependents.Senior Quality Engineer (manufacturing exp. req.) Responsibilities • Design, develop, and enhance manufacturing processes• Develop inspection methods, lead CAPA and root cause analysis, and ensure compliance• Review engineering drawings for tolerancing, manufacturability, and inspection feasibility• Conduct tolerance stack-up analysis and risk assessments and author FMEAs• Develop work instructions, assembly procedures, and maintain BOMs• Troubleshoot production issues and implement corrective actions and lead IQ/OQ/PQ• Design and implement tooling, fixtures, and test equipment for production and validation• Lead continuous improvement initiatives to improve yield, reduce scrap, and increase efficiency• Support product development while ensuring compliance with design control requirements• Develop and execute design verification and validation protocols• Support audits, manage documentation, and design CAD models and tooling in SolidWorksSenior Quality Engineer (manufacturing exp. req.) Qualifications • Bachelor’s degree in engineering• Experience working within a highly regulated environment• Strong experience leading investigations, including CAPA, NCRs, and root cause analysis• Experience developing manufacturing and inspection procedures• Exposure to validation activities (IQ/OQ/PQ), including equipment or process validation• Able to work onsite each day required